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US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them

 
• By Derrick Gingery

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. Pink Sheet charts the approval times and first-cycle clearances over the course of the generic user fee program.

generic drugs
One of the priorities in GDUFA III is to reduce the number of assessment cycles needed to gain approval. • Source: Shutterstock

Generic drug sponsors now can file an ANDA with facilities that are not ready for inspection, but the US Food and Drug Administration is not necessarily suggesting they should.

The new generic drug user fee agreement allows the agency to set a goal date for ANDAs that include facilities...

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